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The Nonin® Onyx Vantage 9590 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on digits, including the thumb and toes, that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The device's intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services, and home healthcare services.

Onyx Vantage 9590 is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the device along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and pulse rate are displayed on the LED display contained within the device. A tricolor LED provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to indicate the pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates an inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by placing on a patient's digit. This simple operation activates the internal circuitry automatically upon application. The device is intended for spot-checking of adult and pediatric patients who are well or poorly perfused on digits, including the thumb and toes.

The provided document is a 510(k) summary for the Nonin Onyx Vantage 9590 Finger Pulse Oximeter. It describes the device and states that it underwent "laboratory and clinical hypoxia accuracy testing in order to ensure that it has appropriate performance, functional features to fully comply with ISO 9919:2005 and is substantially equivalent to the predicate device." However, the document does not provide specific acceptance criteria or detailed results of these tests. It only makes a general statement of compliance.

Therefore, much of the requested information cannot be extracted from this document.

Here's what can be inferred or explicitly stated from the document:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified in the provided document.
• Data provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). It only mentions "laboratory and clinical hypoxia accuracy testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified in the provided document.

4. Adjudication method for the test set

• Not specified in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This device is a pulse oximeter, not an AI-based diagnostic tool that assists human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The device itself is a standalone measurement device (an algorithm-only performance is its primary function). The document states it underwent "laboratory and clinical hypoxia accuracy testing," which would evaluate its standalone performance. However, specific performance metrics are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For oxygen saturation and pulse rate measurements, the "ground truth" in clinical hypoxia accuracy testing typically refers to a co-oximeter (which provides direct arterial oxygen saturation, SaO2) and/or an ECG for pulse rate, often measured from arterial blood samples in a controlled setting. The document only mentions "clinical hypoxia accuracy testing" but does not explicitly state the method for establishing ground truth.

8. The sample size for the training set

• This device is not described as being based on machine learning or AI that requires a "training set" in the conventional sense. Its function is based on established optical principles for measuring pulsing blood volume. Therefore, this concept is not applicable here, and no training set size is mentioned.

9. How the ground truth for the training set was established

• As above, the concept of a training set is not applicable to this device as described.

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